Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.

TORONTO – Opsens Inc. has inked an agreement with Madrid, Spain’s Cathmedical Cardiovascular SA to integrate its coronary physiology algorithms with the Spanish firm’s next generation hemodynamic system, notably Opsens’ diastolic pressure ratio (DPR) for measuring diastolic heart pressure.

The American College of Cardiology (ACC) hopes artificial intelligence (AI) can dramatically increase adoption of its frequently ignored guidelines for cardiovascular care. In three new studies, the ACC will implement Healthreveal's AI to recommend personalized interventions with the goal of preempting adverse cardiovascular events and improving patient outcomes, while increasing physicians’ adherence to guideline-directed medical therapy.

CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.

Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.

PARIS – Imageens SAS just raised a $1.4 million seed round to develop its two artificial intelligence (AI) systems in the field of medical imaging in Europe. Its first solution Artfun+, an AI software application, makes it possible to anticipate cardiovascular pathology thanks to new prognostic biomarkers. Its second product is Label, an algorithm which automatically classifies and assesses medical imaging data.

Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.

The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.